D-MAPPS for Graft-versus-Host Disease

(oGVHD Trial)

Recruiting at 4 trial locations

Overseen By Marissa Harrell, Phd

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Regenerative Ocular Immunobiologics LLC

Must not be taking: Topical steroids, Tacrolimus, Tetracyclines, Antibiotics

Disqualifiers: Rheumatoid arthritis, Lupus, Scleroderma, others

Compensation: Varies

Number of Visits: 3

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test the safety, comfort, and effectiveness of an eye drop treatment called d-MAPPS™ Ophthalmic Solution for individuals with chronic eye issues due to graft-versus-host disease, a condition that can occur after a bone marrow transplant. Participants will use either the d-MAPPS™ eye drops or a placebo (a substance with no therapeutic effect) to compare results. Those experiencing chronic eye problems related to this condition and using devices like scleral lenses or punctal plugs may be suitable for this study. As a Phase 1, Phase 2 trial, this research focuses on understanding how the treatment works in people and measuring its effectiveness in an initial, smaller group, offering participants a chance to contribute to groundbreaking research.

Do I have to stop taking my current medications to join the trial?

The trial does not specify if you need to stop taking your current medications. However, you cannot have significant changes in your systemic immunosuppressive regimen within 2 weeks of starting the study, and you should not change the dosage of tetracycline compounds or the frequency of preserved anti-glaucoma medications close to the study start.

Is there any evidence suggesting that D-MAPPS™ Ophthalmic Solution is likely to be safe for humans?

A previous study found that eye drops made from platelets, similar to D-MAPPS, were safe and well-tolerated for treating eye problems related to graft-versus-host disease (GVHD). Patients generally handled the treatment well without serious side effects. As this trial is in its early stages, the main goal is to assess the safety of D-MAPPS. Although D-MAPPS is still under testing, its similarity to the platelet-based eye drops provides some indication of its potential safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for ocular graft-versus-host disease?

D-MAPPS™ Ophthalmic Solution is unique because it targets graft-versus-host disease (GVHD) in a novel way by being administered directly to the eyes. This is different from standard treatments like systemic immunosuppressants, which can have widespread effects on the body. Researchers are excited because D-MAPPS™ offers a targeted approach, potentially reducing side effects and improving eye-specific outcomes for GVHD patients. Plus, the convenience of self-administering eye drops four times a day might enhance patient adherence compared to more cumbersome treatments.

What evidence suggests that D-MAPPS™ Ophthalmic Solution might be an effective treatment for chronic ocular graft-versus-host disease?

Research shows that d-MAPPS™ Eye Drops are being tested in this trial to determine their effectiveness in treating chronic eye problems caused by graft-versus-host disease (oGVHD). Earlier studies have shown that d-MAPPS™ may ease symptoms of this condition. This treatment reduces inflammation in the eyes, a major issue in oGVHD. Some early signs suggest it might make eyes feel more comfortable and less dry. More research is needed to confirm these effects, but initial results offer hope for patients seeking new treatment options. Participants in this trial will receive either the d-MAPPS™ Eye Drops or a placebo to further evaluate its effectiveness. ^{2 3 6 7 8}

Are You a Good Fit for This Trial?

This trial is for individuals with chronic ocular Graft-Versus-Host Disease (oGVHD), a condition affecting the eyes after stem cell or bone marrow transplantation. Participants should not have high blood pressure to be eligible.

Inclusion Criteria

Minimum Oxford Schema grad of ≥ 1 in at least one eye

Patients may be using bilateral scleral lenses and/or bilateral punctal plugs at the time of accrual

OSDI scored of ≥ 22

Exclusion Criteria

Significant change, as judged by the principal investigator, in systemic immunosuppressive regimen within 2 weeks of study entry

I have a cancer affecting my eye or nearby areas.

I haven't changed my tetracycline medication dose in the last month.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive d-MAPPS™ or placebo, self-administered as 2 drops into each eye four times a day for 90 days

12 weeks

3 visits (in-person) at 30, 60, and 90 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• D-MAPPS™ Ophthalmic Solution

Trial Overview The study tests D-MAPPS™ Ophthalmic Solution against a placebo to evaluate its safety, tolerability, and effectiveness in treating oGVHD. It's a double-masked trial, meaning neither the participants nor the investigators know who receives the real treatment or placebo.

How Is the Trial Designed?

Group I: Both patient and PI are masked. Experimental Treatment 3 Interventions

Upon acceptance into the study, the sponsor will be notified, and the patient will be randomized to the treatment or placebo arm. Randomization Code Key will have limited access to only authorized personnel. Based on the results of the randomization selection, the sponsor will provide the appropriate subject number and lot coded eyedropper bottles containing d-MAPPS™ or Placebo/sterile water to the doctor for dissemination.

Group II: This arm randomizes the actual drug to the patient. Active Control 1 Intervention

Based on randomization, d-MAPPS™ will be self-administered, 2 drops into each eye four times (QID) a day for ninety (90) days.

Group III: This arm randomizes the placebo to the patient. Placebo Group 1 Intervention

Based on randomization Placebo/sterile water, will be self-administered, 2 drops into each eye four times (QID) a day for ninety (90) days.

Who Is Running the Clinical Trial?

Regenerative Ocular Immunobiologics LLC

Lead Sponsor

Trials

1

Recruited

1+

Regenerative Ocular Immunobiologics LLC

Lead Sponsor

Citations

1. trialfinder.panfoundation.org trialfinder.panfoundation.org/en-US/trial/listing/580296

Study of d-MAPPS™ Ophthalmic Solution, Safety ... Study of d-MAPPS™ Ophthalmic Solution, Safety, Tolerability, and Efficacy in the Treatment of Chronic Ocular Graft-Versus-Host Disease (oGVHD).

2. clinicaltrials.gov clinicaltrials.gov/study/NCT07210619

Expanded Access for d-MAPPS™ Ophthalmic Solution, in ... Expanded Access to d-MAPPS™ may be considered for patients with severe chronic ocular GVHD who have no satisfactory alternative treatment ...

3. trial.medpath.com trial.medpath.com/clinical-trial/32e2200e1c15fe28/nct06852768-d-mapps-ophthalmic-solution-ocular-gvhd

Study of d-MAPPS™ Ophthalmic Solution, Safety, Tolerability ... Study of d-MAPPS™ Ophthalmic Solution, Safety, Tolerability, and Efficacy in the Treatment of Chronic Ocular Graft-Versus-Host Disease (oGVHD). Phase 1.

4. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06852768/study-of-d-mappstm-ophthalmic-solution-safety-tolerability-and-efficacy-in-the-treatment-of-chronic-ocular-graft-versus-host-disease-ogvhd?state=CA&city=Huntington%20beach

Study of d-MAPPS™ Ophthalmic Solution, Safety ... Study of d-MAPPS™ Ophthalmic Solution, Safety, Tolerability, and Efficacy in the Treatment of Chronic Ocular Graft-Versus-Host Disease (oGVHD).

5. patlynk.com patlynk.com/trial/NCT07210619

d-MAPPS Ophthalmic Solution for Chronic Ocular Graft- ... This investigational treatment is currently being tested in clinical trials to assess its safety and effectiveness. However, some patients who cannot ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06852768

NCT06852768 | Study of d-MAPPS™ Ophthalmic Solution, ... Study of d-MAPPS™ Ophthalmic Solution, Safety, Tolerability, and Efficacy in the Treatment of Chronic Ocular Graft-Versus-Host Disease (oGVHD) (oGVHD).

7. withpower.com withpower.com/trial/phase-2-graft-vs-host-disease-2025-029e7

D-MAPPS for Graft-versus-Host Disease (oGVHD Trial) The research suggests that platelet-derived eye drops, which may be similar to D-MAPPS, are safe and well-tolerated for treating ocular graft-versus-host ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10333261/

The ocular graft-versus-host disease: the path from current ... Autologous serum eye drops can be used to treat dry eye associated with chronic oGVHD due to its protective and lubricative effects [47].